L29306

 

VINORELBINE TARTRATE (NAVELBINE®)

 

02/02/2009

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Vinorelbine tartrate (Navelbine®)–J9390

 

Medicare will consider Vinorelbine medically reasonable and necessary when provided for its FDA approved uses, as well as for the treatment of the following off-labeled indications:

• Cervical carcinoma.

• Epithelial ovarian carcinoma.

• Metastatic breast carcinoma in patients who did not respond to standard first-line chemotherapy for metastatic disease.

o It is also indicated for patients with metastatic breast cancer who have relapsed within 6 months of anthracycline-based adjuvant therapy.

• Hormone refractory prostate carcinoma.

• Primary peritoneal carcinoma.

• Fallopian tube carcinoma.

 

CPT/HCPCS Codes

 

J9390 INJECTION, VINORELBINE TARTRATE, 10 MG

 

 

ICD-9 Codes that Support Medical Necessity

 

158.8 MALIGNANT NEOPLASM OF SPECIFIED PARTS OF PERITONEUM

158.9 MALIGNANT NEOPLASM OF PERITONEUM UNSPECIFIED

162.0 MALIGNANT NEOPLASM OF TRACHEA

162.2 MALIGNANT NEOPLASM OF MAIN BRONCHUS

162.3 MALIGNANT NEOPLASM OF UPPER LOBE BRONCHUS OR LUNG

162.4 MALIGNANT NEOPLASM OF MIDDLE LOBE BRONCHUS OR LUNG

162.5 MALIGNANT NEOPLASM OF LOWER LOBE BRONCHUS OR LUNG

162.8 MALIGNANT NEOPLASM OF OTHER PARTS OF BRONCHUS OR LUNG

162.9 MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED

174.0 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST

174.1 MALIGNANT NEOPLASM OF CENTRAL PORTION OF FEMALE BREAST

174.2 MALIGNANT NEOPLASM OF UPPER-INNER QUADRANT OF FEMALE BREAST

174.3 MALIGNANT NEOPLASM OF LOWER-INNER QUADRANT OF FEMALE BREAST

174.4 MALIGNANT NEOPLASM OF UPPER-OUTER QUADRANT OF FEMALE BREAST

174.5 MALIGNANT NEOPLASM OF LOWER-OUTER QUADRANT OF FEMALE BREAST

174.6 MALIGNANT NEOPLASM OF AXILLARY TAIL OF FEMALE BREAST

174.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF FEMALE BREAST

174.9 MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE

175.0 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST

175.9 MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST

180.0 MALIGNANT NEOPLASM OF ENDOCERVIX

180.1 MALIGNANT NEOPLASM OF EXOCERVIX

180.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF CERVIX

180.9 MALIGNANT NEOPLASM OF CERVIX UTERI UNSPECIFIED SITE

183.0 MALIGNANT NEOPLASM OF OVARY

183.2 MALIGNANT NEOPLASM OF FALLOPIAN TUBE

183.3 MALIGNANT NEOPLASM OF BROAD LIGAMENT OF UTERUS

183.4 MALIGNANT NEOPLASM OF PARAMETRIUM

183.5 MALIGNANT NEOPLASM OF ROUND LIGAMENT OF UTERUS

183.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF UTERINE ADNEXA

183.9 MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE

185 MALIGNANT NEOPLASM OF PROSTATE

197.6 SECONDARY MALIGNANT NEOPLASM OF RETROPERITONEUM AND PERITONEUM

Diagnoses that Support Medical Necessity

See ICD-9 Codes that Support Medical Necessity

 

Documentation Requirements

• Medical record documentation maintained by the ordering/referring physician must substantiate the medical need for the use of these chemotherapy drugs by clearly indicating the condition for which these drugs are being used.

o This might include the type of cancer, staging, if applicable, prior therapy and the patient’s response to that therapy.

o This documentation is usually found in the history and physical or in the office/progress notes.

• If the provider of the service is other than the ordering/referring physician, that provider must maintain copies of the ordering/referring physician’s order for the chemotherapy drug.

o The physician must state the clinical indication/medical need for using the chemotherapy drug in the order.

Treatment Logic

• Vinorelbine tartrate (Navelbine) is a semi-synthetic derivative of vinblastine.

• It belongs to a group of chemicals called vinca alkaloids. The chemical structure and biological action or vinorelbine is similar to vinblastine and vincristine. Vinorelbine prevents the formation of microtubules in cells.

• One of the roles in microtubules is to aid in the replication of cells.

• By disrupting this function vinorelbine inhibits cell replication, including the replication of cancer cells.

• Vinorelbine is FDA approved for use as a single agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unresectable, advanced non-small cell lung cancer (NSCLC).

• In patients with Stage IV NSCLC, vinorelbine is indicated as a single agent or in combination with cisplatin. In Stage III NSCLC, vinorelbine is indicated in combination with cisplatin.

 

Sources of Information and Basis for Decision

 

Compendia-Based Drug Bulletin. (February 2007). The Association of Community Cancer Centers. [On-Line]. Available: http://www.accc-cancer.org/.

 

FCSO LCD 29306, Vinorelbine Tartrate (Navelbine®), 02/02/2009. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

National Comprehensive Cancer Network (2007). Non-Small Cell Lung Cancer. Clinical Practice Guidelines in Oncology – V.1.2007.

 

Oudard, S., Caty, A., Humblet, Y., Beauduin, M., Suc., E., Piccart, M., Rolland, F., Fumoleau, P., Bugat, R., Houyau, P., Mmonnier, A., Sun, X., Monteuquet, P., Breza, J., Novak, J., Gil, T., & Chopin, D. (2001). Phase II study of Vinorelbine in patients with androgen independent prostate cancer. Annals of Oncology, 12(6), 847-852. This study supports the use of Vinorelbine for the treatment of prostate cancer.

 

Sweeney, C., Monaco, F., Jung, S., Wasielewski, M., Picus, J., Anarsi, R., Dugan, W. & Einhorn, L. (2002). A phase II Hoosier oncology group study of Vinorelbine and estramustine phosphate in hormone-refractory prostate cancer. Annals of Oncology, 16, 435-440. This study supports the use of Vinorelbine for the treatment of prostate cancer.

 

Thomson Micromedex (2007). USP DI Drug Information for the Health Care Professional. [On-Line]. Available: http://www.thomsonhc.com/home/dispatch

 

U.S. Food and Drug Administration, Department of Health and Human Services, CDER web site updates, April 2007.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

CMS LCD VINORELBINE TARTRATE (NAVELBINE®)